Ablation plus immunotherapy versus immunotherapy alone in patients of advanced NSCLC who develop oligo-residual disease after anti-PD-1/L1 therapy (BOOSTER): a randomized phase 2 trial

作者：Shuo Yang, Xinyu Liu, Jia Yu, Xiaoxia Chen, Xiaozhen Liu, Sha Zhao, Tao Jiang, Hui Sun, Meng‐Hang Yang, Fengying Wu, Aiwu Li, Lei Wang, Guanghui Gao, Yaping Xu, Bin Chen, Shengxiang Ren · 发表于：Signal Transduction and Targeted Therapy · 年份：2025 · DOI：10.1038/s41392-025-02460-z · 被引用次数：5 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Diagnosis and Treatment、Interstitial Lung Diseases and Idiopathic Pulmonary Fibrosis

Local consolidative therapy (LCT) has been demonstrated to enhance the survival benefits of immunotherapy in non-small cell lung cancer (NSCLC) patients with oligometastatic or oligoprogressive disease. This randomized, phase 2 trial investigated the efficacy and safety of ablation combining continuous immunotherapy in NSCLC patients with oligo-residual disease (ORD) after anti-PD-1/L1 therapy (ChiCTR, identifier: ChiCTR2000032479). From March 2021 to March 2024, 65 patients were randomly assigned (2:1) to ablation combination group (n = 43) and immunotherapy maintenance group (n = 22), and the full analysis set finally included 42 patients in ablation plus immunotherapy group and 20 patients in immunotherapy maintenance group. With a median follow-up duration of 17.8 months, patients receiving ablation combination were associated with significantly longer PFS (median 26.7 vs. 11.7 months, p < 0.001, HR = 0.213, 95%CI 0.099-0.461) and a trend of longer OS (p = 0.036, HR = 0.242, 95%CI 0.057-1.019) than those without ablation. Subgroup analysis showed that cryoablation (n = 13) yielded potentially superior survival than thermal ablation (n = 31) (mPFS: NA vs. 22.4 months, p = 0.011), which might induced by the elevated level of IFN-α after cryotherapy compared to thermal ablation (p = 0.078). Additionally, ablation combination group showed a decreased rate of systemic progression pattern compared with immunotherapy maintenance group. Regarding safety, the combination of ablati...